Jan 6
Big changes in ISO 14971:2019
Changes in ISO 14971:2019 mean a big change to the medical device industry. ISO 14971:2019 was released mid-December, and the EN version was released on December 18, 2019. The last time this standard was released was 2012, so buckle up folks because this new Risk Management Standard is going to be one roller-coaster ride.
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When designing an electrical or electronic system, product designers may find themselves asking “Should we be spinning a custom PCB (Printed Circuit Board), or hand-wiring on a 
Understanding a differential screw and how to construct one
We asked our development and commercialization experts to share their top medical device commercialization lessons and tips based upon actual medical device development and commercialization experiences. Their recommendations cover projects from working at StarFish as well as other medical device organizations. Many include links to blogs with additional information. Here are 10 ideas to increase your medical device commercialization success in 2020:
The internet is full of great research data. This blog shows how to research four questions one should address when considering Infectious Disease Diagnostics market potential by using public information. I explain how publicly posted research and reports can help analyse and build answers for activities like developing a new PoC Assay.
Negotiating low volume lead supplier times is not without challenges. Vendors can look at low volume quantities or lower dollar value orders as less priority or of importance to fulfill. Adding to this challenge, Just In Time (JIT) delivery is often used to meet on demand client sales orders.
